Maniruzzaman et al., 2016.pdf (461.11 kB)
Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters
journal contribution
posted on 2023-06-09, 04:04 authored by Mohammed Maniruzzaman, Ali NokhodchiCurrently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere.
History
Publication status
- Published
File Version
- Accepted version
Journal
Drug Discovery TodayISSN
1359-6446Publisher
ElsevierExternal DOI
Issue
2Volume
22Page range
340-351Department affiliated with
- Chemistry Publications
Full text available
- Yes
Peer reviewed?
- Yes